Innovative Diagnostic Technologies

Hepatitis C Virus (HCV) TaqMan Assay Armored RNA®

Hepatitis C Virus (HCV) is responsible for most non-A and non-B viral hepatitis in the United States, and is a leading cause of liver failure and membranoproliferative glomerulonephritis (MPGN).

Quantitative measurement of HCV RNA is used to assess the viral load of HCV infected patients and is employed in anti-viral treatment.

The HCV TaqMan Assay is a proprietary technology for specific HCV viral measurements. Every sample is analyzed with a real-time, quantitative PCR-based assay that yields quantitation of viral RNA. An internal RNA control ensures the validity of specimen processing.

Cenetron Diagnostics is the primary inventor of Armored RNA®, which provides custom, stable, quantitative RNA controls for diagnostic assays. This groundbreaking technology provides degradation-resistant quality controls and standards for molecular diagnostic testing.

Armored RNA® stabilizes custom RNA sequences in protective utilizes bacteriophage coat protein. Custom RNA targets form non-infectious, pseudo-viral particles to create ideal standards and controls for RNA viral assays. Armored RNA® is specifically for use as positive controls or quantitative internal spiked controls for amplification and detection using RT-PCR.

 

Patents

DuBois, D.B., M. Winkler, B.L. Pasloske. Ribonuclease resistant viral RNA standards. United States Patent and Trademark Office No. 5677124 October 14, 1997.

B.L. Pasloske, D.B. DuBois, M. Winkler. Method for large scale RNA synthesis and purification. United States Patent and Trademark Office. No. 5919625 July 6, 1999.

B.L. Pasloske, D. DuBois, D. Brown, M. Winkler. Ribonuclease Resistant RNA Preparation and Utilization United States Patent and Trademark Office. No. 5939262 August 17, 1999.

WalkerPeach, C.R., D.B. DuBois. Method for monitoring nucleic acid assays using synthetic internal controls with reversed nucleotide sequences. Patent pending.

 

Publications

Fiscus SA, Brambilla D, Coombs RW, Yen-Lieberman B, Bremer J, Kovacs A, Rasheed S, Vahey M, Schutzbank T, Reichelderfer PS, Group A. Multicenter evaluation of methods to quantitate human immunodeficiency virus type 1 RNA in seminal plasma. J Clin Microbiol. 2000 Jun;38(6):2348-53.

WalkerPeach, C.R., M.Winkler, D.B. DuBois, and B.L. Pasloske. Ribonuclease-resistant RNA controls (Armored RNA) for reverse transcription-PCR, branched DNA, and genotyping assays for hepatitis C virus. Clinical Chemistry 45:2079-2085 (1999).

DuBois , D.B., C.R. WalkerPeach, M.M. Winkler, and B.L. Pasloske. "Standards for PCR Assays" pp. 197-209 in PCR Applications: Protocols for Functional Genomics, M.A. Innis, D.H. Gelfand, and J.J. Sninsky, eds., Academic Press, San Diego (1999).

Palumbo PE, Raskino C, Fiscus S, Pahwa S, Schutzbank T, Spector SA, Baker CJ, Englund JA. Virologic and immunologic response to nucleoside reverse-transcriptase inhibitor therapy among human immunodeficiency virus-infected infants and children. J Infect Dis. 1999 Mar;179(3):576-83.

Sever JL, Rakusan TA, Loechelt B, Schutzbank T, Zamer S, O'Donnell R, Price MV. Variations in HIV-RNA viral load and CD4 counts of infants and children receiving antiretroviral drug therapy. J Clin Virol. 1999 Jan;12(1):71-4.

DuBois, D.B. and C. George Ray "Viral Infections of the Lower Respiratory Tract" in Pediatric Pulmonary Disease, Mosby (1999).

Pasloske, B.L., C.R. WalkerPeach, R.D. Obermoeller, M. Winkler, and D.B. DuBois Armored RNA Technology for Production of ribonuclease-resistant viral RNA controls and standards. J. Clinical Microbiology 36:3590-3594 (1998).

Shalaby-Rana E, Selby D, Ivy P, Schutzbank T, Chan M, Chandra R, Majd M. Multilocular thymic cyst in a child with acquired immunodeficiency syndrome. Pediatr Infect Dis J. 1996 Jan;15(1):83-6.

Stern HJ, Carlos RD, Schutzbank TE. Rapid detection of the delta F508 deletion in cystic fibrosis by allele specific PCR and electrochemiluminescent detection. Clin Biochem. 1995 Aug;28(4):470-3.

Schutzbank TE, Smith J. Detection of human immunodeficiency virus type 1 proviral DNA by PCR using an electrochemiluminescence-tagged probe. J Clin Microbiol. 1995 Aug;33(8):2036-41.

DuBois, D.B., Gretch, C. dela Rosa, W. Lee, J. Fine, C.R. Blagg, and L. Corey. Quantitation of Hepatitis C Viral RNA in Sera of Hemodialysis Patients: Gender Related Differences in Viral Load. Am. J. Kidney Diseases 24:795-801 (1994).

Dennehy PH, Schutzbank TE, Thorne GM. Evaluation of an automated immunodiagnostic assay, VIDAS Rotavirus, for detection of rotavirus in fecal specimens. J Clin Microbiol. 1994 Mar;32(3):825-7.

Carpenter WR, Schutzbank TE, Tevere VJ, Tocyloski KR, Dattagupta N, Yeung KK. A transcriptionally amplified DNA probe assay with ligatable probes and immunochemical detection. Clin Chem. 1993 Sep;39(9):1934-8.

Schutzbank TE, Stern HJ. Principles and applications of the polymerase chain reaction. J Int Fed Clin Chem. 1993 Jul;5(3):96-105.

Rosenthal, J., R. Katz, D.B. DuBois, A. Morrissey, A. Machicao. Chronic maxillary sinusitis associated with the mushroom Schizophyllum commune in a patient with AIDS. Clin. Infectious Diseases 14(1):46-8, 1992.

Lipson SM, Leonardi GP, Salo RJ, Schutzbank TE, Kaplan MH. Occurrence of nonspecific reactions among stool specimens tested by the Abbott TestPack rotavirus enzyme immunoassay. J Clin Microbiol. 1990 Jun;28(6):1132-4.

Madhoun, Z.T., D.B. DuBois, J. Rosenthal, J.C. Findley, and D.C. Aron. Central diabetes insipidus: A complication of herpes simplex type 2 encephalitis in a patient with AIDS. Am. J. Med. 90:658-9 (1991).

Lipson SM, Schutzbank TE, Szabo K. Evaluation of three immunofluorescence assays for culture confirmation and typing of herpes simplex virus. J Clin Microbiol. 1987 Feb;25(2):391-4.

 

Abstracts

D.B. DuBois and M. Gaulden. Increased Sensitivity and Widened Dynamic Range of the Standard COBAS Amplicor HCV Monitor Assay. EASL Annual Meeting, Prague, April 18-23, 2001.

R. Kaspar and D. B. DuBois. The Clinical Course of Severely Immunocompromised Patients Achieving a Re-expansion of CD4 Cells to above 50 cells/mm3 Following Antiretroviral Therapy for HIV-1. 4th Conference on Retroviruses and Opportunistic Infections, Washington DC, January 22-26, 1997.

D.B. DuBois, and R. Kaspar. Lack of Progression to AIDS in Untreated Patients with Low HIV-1 Viral Loads. 4th Conference on Retroviruses and Opportunistic Infections, Washington DC, January 22-26, 1997.

B. Pasloske, D.B. DuBois, and M. Winkler. Novel ribonuclease resistant RNA standards for HIV diagnostics. XI International Conference on AIDS, Vancouver, July 7-12, 1996.

D.B. DuBois, R. Clinton, S.A. Young, R. Mills, P.S. Mitchell, and D.H. Persing. Interlaboratory comparative study of the Amplicor HIV-1 Monitor Assay. 4th Conference on Retroviruses and Opportunistic Infections, Washington DC, January 22-26, 1997.

D.B. DuBois, R. Clinton, T. Lesko, R. Kaspar, K. Blair. High prevalence of seropositive patients in a community clinic with low baseline HIV RNA levels as measured by a quantitative PCR assay. XI International Conference on AIDS, Vancouver, July 7-12, 1996.



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